Verastem

Director Medical Writing - AI Document Lead

Boston, Massachusetts · Director

Sponsorship not specified$220k-$260kDetected 21 days ago

GCPLLMsProject ManagementFDA RegulatoryCommunicationBiostatisticsRegulatory Affairs

About the role

We are seeking an experienced medical writer with deep expertise in clinical and regulatory documents and demonstrated experience using AI-enabled tools to support the development, review, and quality control of clinical documentation.
This individual will contribute to the preparation of high-quality documents such as clinical study protocols, clinical study reports, investigator's brochures, protocol amendments, regulatory briefing materials, and related clinical documents, while also helping to define efficient, compliant, human-in-the-loop workflows for AI-assisted document generation.
The ideal candidate combines strong scientific and regulatory writing judgment with practical experience using generative AI, automation, structured content reuse, and/or document intelligence tools to improve speed, consistency, and quality in medical writing deliverables.

Author, edit, and manage clinical and regulatory documents, including protocols, CSRs, IBs, amendments, clinical summaries, and related submission-supporting materials.
Use AI-enabled tools to support drafting, summarization, content reuse, consistency checks, and document QC while ensuring all outputs are verified against approved source materials.
Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, and other stakeholders to ensure documents are scientifically accurate, submission-ready, and aligned with program strategy.
Support review and adjudication of cross-functional comments, ensuring clear documentation of decisions, source traceability, and final content quality.

Strong understanding of clinical development, GCP, ICH guidelines, and regulatory document standards.
Ability to critically evaluate AI-generated content for scientific accuracy, regulatory appropriateness, source alignment, and completeness.
Excellent written and verbal communication skills, with the ability to synthesize complex clinical and scientific information clearly and accurately.

Experience in oncology or rare disease clinical development.
Experience supporting regulatory submissions or major submission components.
Familiarity with data privacy, information security, validation, and governance considerations for AI-enabled tools in a regulated environment.
Key Success Profile

The base salary range ($220,000 - $260,000) provided reflects our current estimate of what we anticipate paying for this position.

Develop and refine human-in-the-loop workflows for AI-assisted medical writing, including prompt strategies, source document mapping, review checkpoints, and quality controls.
Identify opportunities to improve efficiency across medical writing processes, including document templates, libraries, automation, structured content, and cross-document consistency.
Contribute to best practices, training, and governance for responsible use of AI in clinical and regulatory medical writing.

This listing is sourced directly from Verastem's careers page and normalized into a canonical job model.